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Development and Evaluation of 'My Voice': A Randomized Controlled Trial

Development and Evaluation of 'My Voice': A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06090734
Enrollment
244
Registered
2023-10-19
Start date
2024-03-07
Completion date
2027-03-01
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advance Care Planning, Heart Failure

Brief summary

The study aims to develop and evaluate a web-based interactive platform (called 'My Voice') that helps to educate patients with heart failure and their caregivers about heart failure, identify their goals for end-of-life care, and share these with their caregivers and doctors.

Detailed description

The research study consists of 3 phases: 1. Usability testing - to assess the usability of 'My Voice' with patients with heart failure, their caregivers and healthcare providers, 2. Pilot testing - to test the feasibility of implementation and workflow of 'My Voice' and the survey questionnaires with a small group of participants and, 3. Randomized controlled trial- to evaluate the effectiveness of 'My Voice' with a control group who do not receive the intervention in improving patient outcomes

Interventions

OTHERMy Voice

The web intervention educates patients about their illness and supports them to make their own Advance Care Planning decisions, update these decisions frequently as their clinical condition changes, and to make the ACP process easier and more accessible. The intervention aims to shift implementation of ACP from a provider-led one-time model to a patient-led dynamic model.

Sponsors

Duke-NUS Graduate Medical School
Lead SponsorOTHER
Changi General Hospital
CollaboratorOTHER
Singapore General Hospital
CollaboratorOTHER
Sengkang General Hospital
CollaboratorOTHER
National Heart Centre Singapore
CollaboratorOTHER
Khoo Teck Puat Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- The inclusion criteria for patients are 1. Age ≥ 21 years old 2. Singaporean or Permanent Resident 3. Diagnosed with heart failure 4. Symptoms classified under NYHA class II (with an ejection fraction of less than or equal to 35%), III or IV 5. Intact cognition determined through the Abbreviated Mental Test (AMT) (for pilot testing and main RCT) 6. Ability to speak and read English, Mandarin or Malay 7. Willing to complete a web intervention 8. Easily contactable via mobile phone or landline 9. Have a permanent address in Singapore for at least the next 1 year 10. Not recruited in a previous phase of the study The inclusion criteria for caregivers are 1. Age ≥ 21 years old 2. Nominated as a healthcare spokesperson by the patient or the main decision maker for the patient (for intervention arm only) 3. Ability to speak and read English, Mandarin or Malay 4. Willing to complete a web intervention 5. Easily contactable via mobile phone or landline 6. Have a permanent address in Singapore for at least the next 1 year

Exclusion criteria

for caregivers are: a) domestic helper

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients who have ACP discussions with their treating doctor at least once during the study period1 year from data collectionwill be assessed from medical records and survey
Proportion of patients who have ACP discussions with their caregivers1 year from data collectionwill be assessed from the survey
Proportion of patients who prefer life-extending treatments1 year from data collectionwill be assessed from the survey

Secondary

MeasureTime frameDescription
Proportion of patients with psychological distress1 year from data collectionwill be assessed from the survey
Peace and acceptance scores1 year from data collectionwill be assessed from the survey
Proportion of patients having decision maker1 year from data collectionwill be assessed from the survey

Countries

Singapore

Contacts

PRINCIPAL_INVESTIGATORChetna Malhotra

Duke-NUS Graduate Medical School

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026